Manager, Quality Engineering

Nordson Medical, a global leader in Interventional Solutions, Fluid Components, and Surgical Solutions, is seeking an experienced and highly motivated individual to join our team. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment.

Summary of the role

As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected.

• Provides Quality leadership and partner with site operations leader and/or General Manager to plan and drive quality objectives that accomplish business goals
• Positively represents the site and quality program through best-in-class customer service support to all customers with responsiveness and engagement resulting in Nordson MEDICAL being the customer's supplier of choice
• Provides leadership and expert guidance in technical quality areas including quality engineering, product and process quality, and new product introduction
• Champions quality culture while driving improvements in operations on-time-delivery (OTD) and cost of poor quality (COPQ)
• Champions FOCUS Quality Operating System
• Prioritizes quality engineering and QC work requirements in accordance with production priorities and business needs to maintain efficient flow of product through QC checkpoints according to plan
• Ensures appropriate resources are assigned to execute the various projects, inspections and tests in compliance to the QMS to meet or exceed customer's quality and delivery expectations
• Procures Inspection, Measurement & Test equipment and maintains calibration of this equipment
• Assesses quality engineering and QC team training needs and coordinates and/or delivers appropriate training, cross-training, and coaching
• Ensures all company policies, procedures, standards, and safe work practices are adhered to at all times
• Delivers a talent strategy that builds winning teams through a focus on empathy, integrity, inclusion, learning, and collaboration
• Promotes a culture consistent with Nordson values and Foundational Attributes
• Coaches for development and manages performance and behavior concerns in a timely manner
• Plans quality resources to reduce overhead costs and ensure allocation of resources to business priorities
• ISO and CFR management representative to the QMS with regular reporting to site General Manager and NM Corporate Quality on the status
• Recommends, leads, and drives improvements and lean initiatives for the QMS in support of increased efficiency, and achievement of business and compliance goals
• Liaison between Nordson MEDICAL and our customers in matters related to the QMS including and not limited to the timely execution of customer quality agreements; review of customer specifications; managing external customer audits, first article requests, validation requests, change requests, etc.
• Ensures compliance with all requirements of ISO 13485 and FDA's CFR Part 820 (QSR), and any other applicable standards and regulations
• Manages the NC process including segregation of product, identification, investigation, documentation, and coordinating approval of disposition
• Leads assigned customer complaints and CAPA investigations
• Contributes to business goals through continuous improvement activities
• Develops and uses sampling techniques to determine results of testing
• Ensures DHR reviews are completed
• Establishes and maintains accurate record keeping norms to meet regulatory requirements for Good Documentation Practices (GDP)
• Communicates with customers as needed to support complaint investigations or new product development
• Supports new product development by developing inspection / test methods
• Supports internal, customer, and/or supplier audits as necessary
• Supports document control as a back-up as necessary
• Collaborates closely with other functions such as engineering, operations, etc. to execute QC tasks in accordance with site priorities and initiatives

• Promotes data driven decision making by ensuring required information is maintained in ERP system by the QC team and effectively reporting tiered metrics to site leadership team
• Performs other duties and responsibilities as assigned

Required Education:

• Bachelor's Degree in engineering or other quality related technical field
• ASQ Certified Quality Engineer a plus
• Six Sigma Black Belt Training and/or Certification preferred
• Required Length & Type of Experience:
• Minimum 5 years experience in Quality Control/Assurance or similar technical capacity
• Internal quality system auditing experience for medical devices (ISO 13485) and US FDA Quality
• System Regulation (21 CFR 820) required
• Prior supervisory experience preferred
• Knowledge, Skills & Abilities (KSA's):
• Proficient in Microsoft Office (Excel, Word, Power Point, Outlook)
• Working knowledge of Minitab Statistical Analysis Software
• Strong analytical and problem-solving skills to resolve complex issues and handle multiple projects including statistical analysis and DOE
  

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Interested?

If you are interested in being a part of a team and creating an inclusive and diverse workplace, please apply online with your CV.

About Nordson Medical

At Nordson MEDICAL, you don't have to be a doctor to help save lives. We are the global expert in the design, development, and manufacturing of complex medical devices and component technologies. By joining our team today, you will help us bring innovative ideas to life. Nordson MEDICAL is a global team that works to create components for life-saving medical devices. We offer a supportive culture in a growing and dynamic work environment. Whether you're just beginning your career or you're a seasoned professional, there's a place for you to belong at Nordson MEDICAL. We offer hourly and salary positions in production, maintenance, customer service, quality, engineering, and more. We actively invest in our teams to help you build your skillsets and advance your career.